Quantitative Evaluation of Apathy Close to Real Life Situation by Means of a Multimodal Sensor System Integrated.

NCT02496312 | Completed

• 2 other identifiers: C15-142015-A0087-42
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to provide relevant quantitative evaluation of apathy close to real life situation by means of a multimodal sensor system integrated.

Conditions

Apathy; Behavior; Frontotemporal Dementia

Keywords

Apathy; Goal-directed behavior; Quantitative evaluation; Sensor; Ethogram

Outcome Measures

Primary Outcomes (10)

• Occurrence of each behavior from the ethogram

  \[Provided by the video recording and The Observer NOLDUS software\]

  45 min

• Frequency of each behavior from the ethogram

  \[Provided by the video recording and The Observer NOLDUS software\]

  45 min

• Duration of each behavior from the ethogram

  \[Provided by the video recording and The Observer NOLDUS software\]

  45 mn

• Number of different behaviors

  \[Provided by the video recording and The Observer NOLDUS software\]

  45 mn

• Activity classes

  \[Provided by the MOVE MOVISENS sensor\] lying, sitting, ...

  45 mn

• Body positions

  \[Provided by the MOVE MOVISENS sensor\] lying left, ...

  45 mn

• Energy expenditure

  \[Provided by the MOVE MOVISENS sensor\] kcal.

  45 mn

• MET

  \[Provided by the MOVE MOVISENS sensor\] The Metabolic Equivalent of Task. MET level.

  45 mn

• Steps

  \[Provided by the MOVE MOVISENS sensor\] Counting steps.

  45 mn

• Activity intensity

  \[Provided by the MOVE MOVISENS sensor\] g.

  45 mn

Study Arms (1)

ECOCAPTURE

EXPERIMENTAL

Quantitative Evaluation of Apathy Close to Real Life Situation by Means of a Multimodal Sensor System Integrated.

Behavioral: Evaluation of Apathy Close to Real Life Situation

Interventions

Evaluation of Apathy Close to Real Life Situation BEHAVIORAL

Quantitative Evaluation of Apathy Close to Real Life Situation by Means of a Multimodal Sensor System Integrated.

ECOCAPTURE

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Frontotemporal Dementia (FTD) according to diagnostic criteria reported by Rascovsky et al. (2011).
• Understanding of the instructions and capacity to realize the cognitive tasks.
• Capacity to read, to understand and to sign legal document of information
• Capacity for informed consent for research, capacity to sign consent
• MMSE score \> 20
• Absence of other cerebral pathology.
• Absence of psychiatric disease interfering with the assessment of the tests
• Absence of excessive psychotropic use
• Access to National Healthcare Insurance
• Accompanied with a caregiver

You may not qualify if:

• Excessive psychotropic use
• Incapacity or refusal to realize the experimental tasks
• Subject deprived of freedom by an administrative or court order
• Subject under legal protective measure.
• Incapacity for informed consent for research
• Participation in another biomedical research
• Airway obstruction risk
• Reduction of activity not attributable to another chronic pathological condition

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

CIC de Neurosciences, ICM, hôpital de la Pitiè Salpétrière

Paris, 75013, France

Location

Related Publications (19)

• Robert PH, Clairet S, Benoit M, Koutaich J, Bertogliati C, Tible O, Caci H, Borg M, Brocker P, Bedoucha P. The apathy inventory: assessment of apathy and awareness in Alzheimer's disease, Parkinson's disease and mild cognitive impairment. Int J Geriatr Psychiatry. 2002 Dec;17(12):1099-105. doi: 10.1002/gps.755.

  PMID: 12461757 BACKGROUND

• Pasquier F, Lebert F, Lavenu I, Guillaume B. The clinical picture of frontotemporal dementia: diagnosis and follow-up. Dement Geriatr Cogn Disord. 1999;10 Suppl 1:10-4. doi: 10.1159/000051206.

  PMID: 10436334 BACKGROUND

• Mayo NE, Fellows LK, Scott SC, Cameron J, Wood-Dauphinee S. A longitudinal view of apathy and its impact after stroke. Stroke. 2009 Oct;40(10):3299-307. doi: 10.1161/STROKEAHA.109.554410. Epub 2009 Aug 27.

  PMID: 19713543 BACKGROUND

• Winograd-Gurvich C, Fitzgerald PB, Georgiou-Karistianis N, Bradshaw JL, White OB. Negative symptoms: A review of schizophrenia, melancholic depression and Parkinson's disease. Brain Res Bull. 2006 Oct 16;70(4-6):312-21. doi: 10.1016/j.brainresbull.2006.06.007. Epub 2006 Jul 5.

  PMID: 17027767 BACKGROUND

• Marin RS, Firinciogullari S, Biedrzycki RC. Group differences in the relationship between apathy and depression. J Nerv Ment Dis. 1994 Apr;182(4):235-9. doi: 10.1097/00005053-199404000-00008.

  PMID: 10678322 BACKGROUND

• Dujardin K, Sockeel P, Delliaux M, Destee A, Defebvre L. The Lille Apathy Rating Scale: validation of a caregiver-based version. Mov Disord. 2008 Apr 30;23(6):845-9. doi: 10.1002/mds.21968.

  PMID: 18307266 BACKGROUND

• Lane-Brown AT, Tate RL. Apathy after acquired brain impairment: a systematic review of non-pharmacological interventions. Neuropsychol Rehabil. 2009 Aug;19(4):481-516. doi: 10.1080/09602010902949207.

  PMID: 19533496 BACKGROUND

• Czernecki V, Pillon B, Houeto JL, Welter ML, Mesnage V, Agid Y, Dubois B. Does bilateral stimulation of the subthalamic nucleus aggravate apathy in Parkinson's disease? J Neurol Neurosurg Psychiatry. 2005 Jun;76(6):775-9. doi: 10.1136/jnnp.2003.033258.

  PMID: 15897497 BACKGROUND

• Le Jeune F, Drapier D, Bourguignon A, Peron J, Mesbah H, Drapier S, Sauleau P, Haegelen C, Travers D, Garin E, Malbert CH, Millet B, Verin M. Subthalamic nucleus stimulation in Parkinson disease induces apathy: a PET study. Neurology. 2009 Nov 24;73(21):1746-51. doi: 10.1212/WNL.0b013e3181c34b34.

  PMID: 19933975 BACKGROUND

• Marin RS. Apathy: a neuropsychiatric syndrome. J Neuropsychiatry Clin Neurosci. 1991 Summer;3(3):243-54. doi: 10.1176/jnp.3.3.243.

  PMID: 1821241 BACKGROUND

• Levy R, Dubois B. Apathy and the functional anatomy of the prefrontal cortex-basal ganglia circuits. Cereb Cortex. 2006 Jul;16(7):916-28. doi: 10.1093/cercor/bhj043. Epub 2005 Oct 5.

  PMID: 16207933 BACKGROUND

• Levy R, Czernecki V. Apathy and the basal ganglia. J Neurol. 2006 Dec;253 Suppl 7:VII54-61. doi: 10.1007/s00415-006-7012-5.

  PMID: 17131230 BACKGROUND

• Brown RG, Pluck G. Negative symptoms: the 'pathology' of motivation and goal-directed behaviour. Trends Neurosci. 2000 Sep;23(9):412-7. doi: 10.1016/s0166-2236(00)01626-x.

  PMID: 10941190 BACKGROUND

• Muller U, Czymmek J, Thone-Otto A, Von Cramon DY. Reduced daytime activity in patients with acquired brain damage and apathy: a study with ambulatory actigraphy. Brain Inj. 2006 Feb;20(2):157-60. doi: 10.1080/02699050500443467.

  PMID: 16421064 BACKGROUND

• Funkiewiez A, Bertoux M, de Souza LC, Levy R, Dubois B. The SEA (Social cognition and Emotional Assessment): a clinical neuropsychological tool for early diagnosis of frontal variant of frontotemporal lobar degeneration. Neuropsychology. 2012 Jan;26(1):81-90. doi: 10.1037/a0025318. Epub 2011 Sep 5.

  PMID: 21895376 BACKGROUND

• Batrancourt B, Lecouturier K, Ferrand-Verdejo J, Guillemot V, Azuar C, Bendetowicz D, Migliaccio R, Rametti-Lacroux A, Dubois B, Levy R. Exploration Deficits Under Ecological Conditions as a Marker of Apathy in Frontotemporal Dementia. Front Neurol. 2019 Aug 28;10:941. doi: 10.3389/fneur.2019.00941. eCollection 2019.

  PMID: 31551908 RESULT

• Tanguy D, Rametti-Lacroux A, Bouzigues A, Saracino D, Le Ber I, Godefroy V, Morandi X, Jannin P, Levy R, Batrancourt B, Migliaccio R; ECOCAPTURE Study Group. Behavioural disinhibition in frontotemporal dementia investigated within an ecological framework. Cortex. 2023 Mar;160:152-166. doi: 10.1016/j.cortex.2022.11.013. Epub 2022 Dec 28.

  PMID: 36658040 RESULT

• Godefroy V, Batrancourt B, Charron S, Bouzigues A, Bendetowicz D, Carle G, Rametti-Lacroux A, Bombois S, Cognat E, Migliaccio R, Levy R. Functional connectivity correlates of reduced goal-directed behaviors in behavioural variant frontotemporal dementia. Brain Struct Funct. 2022 Dec;227(9):2971-2989. doi: 10.1007/s00429-022-02519-5. Epub 2022 Jun 25.

  PMID: 35751676 RESULT

• Godefroy V, Batrancourt B, Charron S, Bouzigues A, Sezer I, Bendetowicz D, Carle G, Rametti-Lacroux A, Bombois S, Cognat E, Migliaccio R, Levy R. Disentangling Clinical Profiles of Apathy in Behavioral Variant Frontotemporal Dementia. J Alzheimers Dis. 2022;90(2):639-654. doi: 10.3233/JAD-220370.

  PMID: 36155506 RESULT

MeSH Terms

Conditions

Lethargy; Behavior; Frontotemporal Dementia

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Richard LEVY, PhD, MD

  INSERM UMR_S 1127, ICM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 14, 2015
• Study Start: July 10, 2015
• Primary Completion: October 2, 2015
• Study Completion: October 2, 2015
• Last Updated: June 5, 2026

Record last verified: 2017-10

Locations

FR (1)